DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
1) Acknowledgment is made of Applicant’s preliminary amendment filed 04/13/2026.
Election
2) Acknowledgment is made of Applicant’s election filed 04/13/2026 in response to the species election requirement mailed 02/11/2026. Applicant has elected, with traverse, the Bacillus genus and the Bacillus subtilis probiotic organism species along with the deletion of all other probiotic organism species from claims 3, 4, 13 and 14. Accordingly, Applicant’s traversal set forth on pages 8-10 of the election filed 04/13/26 is moot.
Status of Claims
3) Claims 3, 4, 13 and 14 have been amended via the preliminary amendment filed 04/13/26.
Claims 1-20 are pending and are examined on the merits.
Drawings
4) Applicant’s drawings filed 03/21/24 are acknowledged.
Priority
5) The instant AIA application, filed 03/21/2024, claims the benefit of the US provisional application 63/497,424 filed 04/20/2013.
Rejection(s) under 35 U.S.C § 112(b) or Pre-AIA , Second Paragraph
6) The following is a quotation of 35 U.S.C § 112(b):
(B) CONCLUSION --The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7) Claims 1-20 are rejected under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite, for failing to particularly point out and distinctly claim the subject matter which inventor or a joint inventor regards as the invention.
(a) Claim 1 is ambiguous, confusing and indefinite in the inconsistent plural and non-plural limitations “probiotic microorganisms” (see line 1) and “the probiotic microorganism’s” (see line 6). Said inconsistency renders the scope of the claim indeterminate. One of ordinary skill cannot understand in an unambiguous way that the subject matter that is being claimed and the scope of the claim. The claim fails to distinctly claim the subject matter.
(b) Analogous rejection applies to claim 11 with regard to the ambiguous, confusing, indefinite and inconsistent plural and non-plural limitations “probiotic microorganisms” (see line 1) and “the probiotic microorganism’s” (see line 6).
(c) Claim 1 is further indefinite for having improper and/or confusing antecedence in the limitation “the probiotic microorganism’s” in line 6. Note that the prior recitation in line 1 of the claim is of the plural “probiotic microorganisms”.
(d) Claims 1 and 11 are further ambiguous and indefinite in having improper antecedence with regard to the limitation “the bacterium”. See line 7. Note that there is no prior recitation in these claims of a “bacterium”. One of ordinary skill cannot understand in an unambiguous way the subject matter that is being claimed and the scope of the claims. The claims fail to distinctly claim the subject matter.
(e) Claims 1 and 11 are further ambiguous and indefinite with regard the elements comprised in the claimed composition. Line 1 of the claim indicates that the claimed composition comprises recombinant plural “probiotic organisms”, whereas part c) of the claim indicates that the claimed composition also comprises “the bacterium including a genetic modification that induces .....” which a genetic modification, with no antecedence, is other than “the genetic modification” recited in part b) of the claim. Part b) of the claim conveys that the scope of the claim includes the recited non-plural “the probiotic microorganism”. One of ordinary skill cannot understand in an unambiguous way the subject matter that is being claimed and the scope of the claims. The claims fail to distinctly claim the subject matter.
(f) Claims 1 and 11 are further indefinite in having improper antecedence in the limitation “the genetic modification” at the beginning of part b) of the claims. There is no prior recitation a genetic modification in the claims.
(g) Claims 2 and 12 are indefinite for having improper antecedence in the limitation “said telomerase genes” [Emphasis added]. See lines 2 and 3. Claims 2 and 12 depend from claims 1 and 11 respectively which do not recite plural telomerase genes.
(h) Claim 2 is ambiguous and indefinite for having confusing and/or improper antecedence in the limitation “said genetic modifications ..... that regulate expression of said ..... genes in said probiotic organism”. Claim 2 depends from claim 1, part b) of which recites the non-plural “the probiotic organism”. Are the recited “said genetic modifications ....” limited to “said probiotic organism”, but not to the recombinantly engineered ‘probiotic organisms?
(i) Claim 12 is indefinite for having improper antecedence in the limitation “said probiotic strain”. See last line. Claim 12 depends from claim 11 which does not recite any probiotic strain.
(j) Claims 10 and 20 are indefinite for having improper antecedence in the limitation “the cultured fermentation” [Emphasis added]. See last line.
(k) Claims 2-20, which depend directly or indirectly from claim 1 or claim 11, are also rejected as being indefinite because of the indefiniteness identified above in the base claim.
Rejection(s) under 35 U.S.C § 112(a) or Pre-AIA , First Paragraph
8) The following is a quotation of 35 U.S.C § 112(a):
(a) IN GENERAL. - The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out the invention.
9) Claims 1-20 are rejected under 35 U.S.C § 112(a) as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant application, an attempt to analyze the scope of the claims and of the variant genus encompassed therein indicates the following.
The independent claims 1 and 11 are representative of the claimed invention. Claim 1 is drawn to a composition comprising recombinant “probiotic organisms” recombinantly engineered to express an enzyme involved in maintaining the length of telomers, the enzyme comprising telomerase subunits, wherein the genetic modification comprises an operon that includes a promoter recognized by “the” probiotic “organism’s” RNA polymerase and a gene sequence encoding telomerase; “the bacterium” includes ‘a genetic modification’ that induces secretion of telomerase into a host organism; and wherein the genetic modification of the telomerase gene sequence enhances the telomerase enzyme entrance into the host organism’s cells. Claim 11 is also drawn to a similar composition. Claim 2 depends from said claim 1 and recites “said genetic modifications” comprising one or more nucleic acid sequences encoding transcription factors that regulate expression of “said telomerase genes” in “said” probiotic organism. Thus, in the dependent claim 2, it appears that “said genetic modifications ..... that regulate expression of said telomerase genes” are limited to “said probiotic organism”. Claim 12 depends from claim 11 and recites “said genetic modifications” comprising one or more nucleic acid sequences encoding transcription factors that regulate expression of “said telomerase genes” in “said” probiotic strain”. The limitation “said genetic modifications” in the dependent claim 2 includes all of “the genetic modification” recited in part a) of claim 1, “a genetic modification” recited in part c) of claim 1, and “the genetic modification” recited in part d) of claim 1. This is also the case in the dependent claim 12. The above-identified plural and non-plural inconsistencies associated with the limitations “probiotic organisms” and “the probiotic organism”; the limitations “a genetic modification” and “said genetic modifications”; and the limitations “a gene sequence encoding telomerase” and “said telomerase genes” as well as the limitation with improper antecedence “the bacterium” including a genetic modification that induces secretion of telomerase into a host organism -- all render the scope of the claims and the various elements contained within the claimed recombinantly engineered product and within the claimed composition indeterminate. With all these inconsistencies and due to the incomprehensible nature of the claims, one of skill in the art cannot perform a meaningful analysis of the scope of the claims and cannot understand the various elements comprised in the claimed composition. If one interpreted the claimed composition as comprising, within its broad scope, recombinantly engineered plural probiotic organisms of broader scope expressing any generic enzyme comprising therein telomerase subunits and comprising an operon including a promoter recognized by RNA polymerase of the generically recited probiotic organism’s, i.e., generic probiotic organism not required to be recombinantly engineered, and a gene encoding telomerase as well as comprising the recited ‘the bacterium’ of narrower scope recited in part c) of claims 1 and 11, the bacterium including a genetic modification that induces secretion of telomerase, i.e., a telomerase that is not required to be the telomerase recited in part b), the plural ‘recombinant probiotic organisms’, the non-plural probiotic organism, and ‘the bacterium’ – all represent a huge genus encompassing innumerable genetically, taxonomically, antigenically, and structurally divergent species possessing variable phylogenetic, structural and antigenic characteristics. The limitation ‘a host organism’ encompasses within its broad scope eukaryotic and prokaryotic organisms, probiotic and non-probiotic organisms etc. The genetic modification of the telomerase gene sequence is required to enhance the telomerase enzyme into a host organism’s cells; and the recombinantly engineered probiotic organisms having all the genetic modifications are required to constitutively express an enzyme involved in maintaining the length of telomers. Per claims 7 and 17, the broadly claimed recombinantly engineered probiotic organisms comprising the genetic modifications as claimed with a stabilizing agent therein, are required to have enhanced viability not only during storage but are also required to have enhanced viability in vivo upon administration of the composition, by any route, to the host organism. Since the claimed composition is a pharmaceutical composition as claimed in claims 4-10 and 15-20, the claimed recombinantly engineered probiotic organisms comprising the genetic modifications as claimed are required to have pharmaceutical functions. However, there is absolutely no evidence within the as-filed specification that, at the time of the invention or as of the effective filing date of the instant application, Applicant was in possession of a representative number and variety of species within each variable genus comprised in the claimed composition, wherein the structure of the species within the genus is correlated with the functional capacity to constitutively express a generic enzyme comprising telomerase subunits, the enzyme being involved in maintaining the length of telomers, wherein the genetic modification of the telomerase gene sequence enhances the telomerase enzyme into a host organism’s cells, and wherein the probiotic organism species have enhanced viability upon administration in vivo. Applicant was in not possession of a composition as claimed having the requisite pharmaceutical functions.
The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics, and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002). Sufficient description to show possession of a genus may be achieved by means of description of a substantial number of the members or species of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would allow the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicant has not described a sufficient number and variety of the species in the claimed composition that are representative of the huge genus of antigenically, genetically, taxonomically, and functionally highly variable plural probiotic organisms species, non-plural probiotic organism species, and the bacterium species, each having the recited genetic modifications including the genetic modification species that enhance the telomerase enzyme entrance into the host organism’s cells. A representative number and variety of each of the broad genus comprised in the claimed composition have not been correlated with the requisite functions. Note that possession may not be shown by merely describing how to obtain members of the claimed genus or how to identify their common structural features. Applicant should note that written description requires more than a mere statement that something is a part of the invention and a reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. A mere statement that the invention includes the elements as recited in the claims is insufficient to meet the adequate written description requirement of the claimed invention. A convincing structure-function relationship must exist between the structure of a representative number of the various species encompassed within each genus and the requisite function(s). A mere idea or unsubstantiated function is insufficient for written description; characterization of a representative number of species in an unpredictable art such as biotechnological art, with their precise structure correlated with the requisite functions, is required in order to claim the broad genus. Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) states:
"When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" [Emphasis added].
The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicant was in possession of each of the variant genus identified supra and the full scope of the claimed invention at the time of filing. Clearly, Applicant was not in possession of the full scope of the variable genus and of the composition as claimed at the time of the invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Possession may be shown in a variety of ways including by showing that the invention was “ready for patenting”. MPEP 2163. MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided that the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 U.S.C § 112(a) or 35 U.S.C § 112(pre-AIA ), first paragraph is severable from its enablement provision. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph. Clearly, Applicant did not describe the invention of the instant claims sufficiently to show that he/she had possession of the claimed broad method. Instant claims do not meet the provision of 35 U.S.C § 112 (pre-AIA ), first paragraph or 35 U.S.C § 112(a).
Rejection(s) under 35 U.S.C § 112(b) or Pre-AIA , Second Paragraph
10) The following is a quotation of 35 U.S.C § 112(b):
(B) CONCLUSION --The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
11) Claims 1-20 are rejected under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite, for failing to particularly point out and distinctly claim the subject matter which inventor or a joint inventor regards as the invention.
(a) Claim 1 is ambiguous, confusing and indefinite in the inconsistent plural and non-plural limitations “probiotic microorganisms” (see line 1) and “the probiotic microorganism’s” (see line 6). One of ordinary skill cannot understand in an unambiguous way that which is being claimed. Said inconsistency renders the scope of the claim indeterminate. One of ordinary skill cannot understand in an unambiguous way that the subject matter that is being claimed and the scope of the claim. The claim fails to distinctly claim the subject matter.
(b) Analogous rejection applies to claim 11 with regard to the ambiguous, confusing, indefinite and inconsistent plural and non-plural limitations “probiotic microorganisms” (see line 1) and “the probiotic microorganism’s” (see line 6).
(c) Claim 1 is further indefinite for having improper and/or confusing antecedence in the limitation “the probiotic microorganism’s” in line 6. Note that the prior recitation in line 1 of the claim is of the plural “probiotic microorganisms”.
(d) Claims 1 and 11 are further ambiguous and indefinite in having improper antecedence with regard to the limitation “the bacterium”. See line 7. Note that there is no prior recitation in these claims of a “bacterium”. One of ordinary skill cannot understand in an unambiguous way the subject matter that is being claimed and the scope of the claims. The claims fail to distinctly claim the subject matter.
(e) Claims 1 and 11 are further ambiguous and indefinite with regard the elements comprised in the claimed composition. Line 1 of the claim indicates that the claimed composition comprises recombinant plural “probiotic organisms”, whereas part c) of the claim indicates that the claimed composition also comprises “the bacterium including a genetic modification that induces .....” which genetic modification is other than “the genetic modification” recited in part b) of the claim. Part b) of the claim conveys that the composition also comprises the recited non-plural “the probiotic microorganism”. One of ordinary skill cannot understand in an unambiguous way the subject matter that is being claimed and the scope of the claims. The claims fail to distinctly claim the subject matter.
(f) Claims 1 and 11 are further indefinite in having improper antecedence in the limitation “the genetic modification” at the beginning of part b) of the claims. There is no prior recitation a genetic modification in the claims.
(g) Claims 2-20, which depend directly or indirectly from claim 1 or claim 11, are also rejected as being indefinite because of the indefiniteness identified above in the base claim.
Objections to Claims & Specification
12) Claims 3, 4, 13 and 14 and the specification are objected to for the following reasons:
(a) Claims 4 and 14 are objected to for the non-italicized limitation “Bacillus subtilis”. To be consistent with the practice in the art of scientific nomenclature of bacterial species, it is suggested Applicant delete the above-identified non-italicized limitation via strikethrough, i.e., Bacillus subtilis, with the italicized limitation --Bacillus subtilis-- with underlining, i.e., Bacillus subtilis.
(b) Analogous objection and suggestion apply to claims 3 and 13 with regard to the non-italicized limitation “Bacillus”.
(c) All non-italicized recitations of names of the various bacterial species and genera such as Bacillus, Bacillus subtilis, Escherichia, Lactobacillus and so on, throughout the specification are objected to. To be consistent with the practice in the art of scientific nomenclature of bacterial genus and species and of microorganisms, all such recitations should be italicized via deletion of the non-italicized limitations via strikethrough and replacing with underlined italicized limitations as suggested in paragraphs (a) and (b) supra.
Conclusion
13) No claims are allowed.
A thorough and meaningful search and/or examination of the instant claims are not possible due to the multiple indefiniteness and inconsistency issues identified supra, which render the scope of the claims incomprehensible and the interpretation of the claims impossible. Due to the indeterminate metes and bounds of the claims, no prior art comparison and thus no determination of prior art applicability is possible currently.
Correspondence
14) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
15) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
July, 2026
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